Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – C-o-group doai
Reexamination Certificate
1997-12-24
2001-11-20
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
C-o-group doai
C424S401000, C514S844000, C514S859000, C514S863000
Reexamination Certificate
active
06319957
ABSTRACT:
TECHNICAL FIELD
The present invention relates to cosmetic compositions which may be applied to any part of the skin of the human body, including the scalp and genital organs, for effectively reducing and/or gradually eliminating unsightly skin disorders such as stretch marks, acne, scars, dark spots and incipient baldness, and which are also highly effective in, treating mycosis and psoriasis. The present invention also relates to a cosmetic method of employing such compositions.
BACKGROUND ART
Many people suffer from unsightly skin disorders caused by diseases or deterioration of more or less extensive portions of the skin, e.g. acne, scars resulting from accidents, wrinkles, stretch marks, blackheads, dark spots, and which are often accompanied by excessive sebum secretion and, at times, by actual diseases often caused by mycotic infections such as psoriasis, pityriasis, onychomycosis, etc.
At present, people suffering from such problems must use a variety of either medicinal or cosmetic products (antimycotics, wrinkle removers, etc.), each limited to the treatment of a specific disorder. Acne, for example, is treated using medicaments based on retinoic acid (tretinoin, isotretinoin), but which are indicated exclusively for the treatment of acne. In more serious cases, again of acne for example, recourse must be made to surgery to remove the affected skin portions, owing to the failure of known medicinal remedies not only to arrest the disease but also to even partly repair the damage already produced to the skin.
DISCLOSURE OF INVENTION
It is an object of the present invention to provide a cosmetic and, at the same time, antimycotic composition capable of regenerating the affected skin regions and so gradually reducing and eventually attenuating and/or eliminating the above disorders.
It is a further object of the present invention to provide cosmetic compositions which, in addition to being cosmetic, are also highly effective in the treatment of psoriasis, even severe, recurrent cases involving extensive skin regions.
According to the present invention, there is provided a cosmetic, antimycotic composition for skin application, in particular for treating unsightly skin disorders such as acne, stretch marks, scars and dark spots;
characterized by comprising at least a glycol or glyceric ester of retinoic acid dissolved in a glyco-alcohol, hydro-alcohol or glyco-hydro-alcohol solution.
Preferably, the composition also comprises, in combination, the ethyl ester of retinoic acid and hydroquinone, both also dissolved in said glyco-alcohol, hydro-alcohol or glyco-hydro-alcohol solution.
More specifically, said glyco-alcohol solution comprises propylene glycol and, in lesser proportions, ethyl alcohol; and also contains propylene glycol ether.
In the case in point, one composition according to the invention comprises a glyco-alcohol solution of 0.10 to 0.25 N of ethyl ester of retinoic acid, and 0.15 to 0.30 N of glycopropylene ester of retinoic acid. Preferably, said glyco-alcohol solution presents a propylene glycol base, and also contains 0.001 to 0.002 N of ethyl-glycopropylene ether.
As stated in the introduction, retinoic acid as such is already known as a product for the treatment of acne, and is preferably obtained from its ethyl ester. Its direct “clinical” use, however, in the form of ethyl and, more especially, glycopropyl ester, and its association with hydroquinone in a glyco- and/or hydro-alcohol solution, are entirely new, and have surprisingly resulted in a product which is equally effective in the treatment of any other unsightly skin disorder, and which produces a marked peeling effect (desquamation of the surface layers of the skin) with a visible improvement in the tone, firmness and luminosity of the skin, a visible reduction of small wrinkles, and a marked reduction of deeper wrinkles, together with a reduction in excess sebum secretion.
In the case of acne, repeated use of the composition according to the invention provides for a marked improvement after only a few applications (five on average) and eventually total elimination. The composition according to the invention is also a highly effective antimycotic for curing diseases such as pityriasis, versicolor and onychomycosis after only two/four applications (one a week), and also provides for a marked improvement and for eventually curing psoriasis.
Clinical tests have shown no appreciable side effects, with the exception of individual hypersensitivity to one of the components, and headaches accompanied or not by itching of the treated parts in the case of product abuse.
The composition according to the invention may be marketed and used in the form of a solution applied using cotton cloth, cotton-wool, tissues or sponges soaked in the solution, or may comprise solid or semisolid excipients in which the glyco-alcohol solution is dispersed to form a cream, in which case, however, the peeling effect is reduced or entirely eliminated.
According to a preferred embodiment of the present invention, the composition therefore also comprises solid or semisolid excipients in which 2-10% by weight of said glyco-alcohol, hydro-alcohol or glyco-hydro-alcohol solution of said esters of retinoic acid is dispersed, so that the composition according to the invention is in the form of a cream.
The composition according to the invention may optionally comprise a cortisone, an anti-inflammatory substance, one or more liposoluble vitamins, and salicylic acid as such or in the form of glycol ester. More specifically, said anti-inflammatory substance is selected from the group comprising: niflumic acid, indomethacin and naproxene.
Alternatively, the composition according to the invention may comprise sodium heparin in gel form to enhance the anti-edema effect.
The composition according to the invention is prepared by producing an esterification reaction between retinoic acid and propylene glycol in a glyco-alcohol solution with a large excess of propylene glycol, so that substantially all the retinoic acid in the solution is esterified; and, after the esterification reaction, the solution is used as such, without removing the surplus reactants or the reaction products. The reaction is preferably conducted in the presence of 1.35% to 23.9% by weight of hydroquinone in the glyco-alcohol solution, and by catalyzing the reaction by heating the reaction mixture and/or by performing the reaction in the presence of an acid substance, e.g. salicylic acid, hydrochloric acid or thionyl chloride.
It is a further object of the present invention to provide cosmetic methods of treating unsightly skin disorders such as acne, scars, stretch marks and dark spots, and enabling results at various levels ranging from simply invigorating “healthy” skin to gradually attenuating (and eventually eliminating or practically eliminating) the disorder.
In general, a cosmetic method in accordance with the present invention is characterized in that:
glycol or glyceric ester of retinoic acid is prepared in a glyco-alcohol solution by esterifying the acid with the corresponding polyalcohol and operating with a large excess of polyalcohol in the presence of hydroquinone; and
the resulting solution, containing the ester produced by the reaction, and possibly aged in atmospheric air at ambient temperature, is subsequently applied to the skin region for treatment to produce surface peeling of the region.
According to a first embodiment of the above cosmetic method, the glycopropylene ester of retinoic acid is prepared in a first solution comprising propylene glycol as the only solvent and containing 0 to 8.5% by weight, of the total weight of the solution, of hydroquinone, by dissolving, in said solution, 0.01 to 4% by weight, of the total weight of the solution, of retinoic acid; and said solution containing the prepared ester is subsequently applied to the skin region for treatment.
According to a second embodiment of the cosmetic method according to the invention, a mixture of glycopropylene and ethyl esters of retinoic acid is prepared in a second solution c
Dees Jose′ G.
Lamm Marina
Schlesinger Arkwright & Garvey LLP
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